We currently have an exciting new opportunity for an Associate Project Manager to join our growing team, sponsor dedicated.
The Associate PM is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management.
This is a permanent role with ICON and fully home-based.
You must be located in the following countries to be consider: Bulgaria, Poland, Spain and UK.
Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
Contributes to the planning and conduct of internal and external meetings (e.g., Investigators'/Monitors' meeting).
Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
Ensures that all study documents in scope of global associate project manager responsibilities are complete and verified for quality in Trial Master File.
Supports Global Study Directors and/or GSAD with budget management, such as external service provider invoice reconciliation.
Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
Supports Global Study Directors and/or GSAD with overall project management as per agreed delegation.
For outsourced studies, supports Global Study Directors and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Vendor management experience Knowledge of clinical development / drug development process in various phases of development and therapy areas Excellent knowledge of international guidelines ICH/GCP Excellent communication and relationship building skills, including external service provider management skills Good project management skills Demonstrated ability to collaborate as well as work independently Demonstrated leadership skills Computer proficiency, advanced You MUST be located in the following countries to be considered: Poland, Spain, UK, Bulgaria, no other countries will be considered at this time.
You MUST come from a Clinical Research background and doing either of the following roles or similar: Global Clinical Trial Administrator, Project Specialist supporting the global clinical study team, CRA, In-House CRA.
Must have Global experience supporting the oversight of multiple countries at one time.
(Local experience will not be considered)
